Catheter assembly

ABSTRACT

A catheter assembly is disclosed, which includes a catheter; a catheter hub fixed to a proximal end portion of the catheter; a needle having a needlepoint, and inserted into the catheter so as to be separable; an elongated member coupled to the needle; a protector displaceable in an axial direction in a range regulated with respect to the elongated member, and configured to cover at least the needlepoint of the needle in accordance with evulsion of the needle from the catheter; and wherein, in an initial state, the catheter and the needle are exposed from a distal end of the elongated member, and the elongated member overlaps the catheter hub and the protector.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/237,384, filed on Dec. 31, 2018, which is a continuation of U.S.patent application Ser. No. 15/220,791 filed on Jul. 27, 2016, which isa continuation of International Application No. PCT/JP2015/051777 filedon Jan. 23, 2015, which claims priority to Japanese Application No. JP2014-014123 filed on Jan. 29, 2014, the entire contents of all four ofwhich are hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure relates to a catheter assembly that punctures ablood vessel and can be, for example, detained upon performing atransfusion to a patient.

BACKGROUND DISCUSSION

Conventionally, when a transfusion is performed to a patient, forexample, a catheter assembly is used. The catheter assembly can includea hollow catheter, a catheter hub adhered to a base end (i.e., proximalend) of the catheter, an inner needle inserted into the catheter andhaving a sharp needlepoint at a leading end (i.e., distal end), and aneedle hub adhered to a base end of the inner needle. In a case where atransfusion is performed to a patient by using the catheter assembly,the catheter with the inner needle punctures a blood vessel of thepatient, and the inner needle is evulsed from the catheter while thecatheter is puncturing the patient after the puncture. Next, a connectorprovided at an end portion of a transfusion tube is coupled to a baseend of the catheter hub, and a transfusion material is supplied into theblood vessel of the patient through the transfusion tube, the catheterhub, and the catheter.

In the use of the above catheter assembly, in order to help prevent auser from carelessly touching an inner needle having a sharp needlepointafter the inner needle has been evulsed from a catheter, a catheterassembly including a protector, capable of covering the inner needleafter the evulsion has been proposed (for example, refer to JP 3808806B1).

In a case of the conventional catheter assembly including a protector, aneedle hub is constituted as a housing. In an initial state (beforeuse), a leading end of the housing can include a base end of a catheterhub positioned thereat, and an exposure length of the inner needle fromthe housing is long. When a protecting function of the protectorappears, a state where the protector that has been housed in the housingprotrudes from the leading end of the housing and covers the innerneedle protruding from the housing with the needlepoint, is acquired.Due to the above configuration, the conventional catheter assemblyincluding a protector has a long entire product length in both theinitial state and the needlepoint protecting state.

SUMMARY

It would be desirable to have a catheter assembly having a shorterentire product length, and which can have excellent storage before useand can be relatively easy to use due to its compactness. In addition,waste after use is relatively compact, and waste disposal can beperformed relatively easily.

A catheter assembly is disclosed capable of shortening an entire productlength in comparison to a conventional catheter assembly including aprotector.

A catheter is disclosed, which includes a catheter hub fixed to a baseend portion of the catheter; an inner needle having a needlepoint, andinserted into the catheter so as to be separable; a housing coupled tothe inner needle; and a protector displaceable in an axial direction ina range regulated with respect to the housing, and configured to coverat least the needlepoint of the inner needle in accordance with evulsionof the inner needle from the catheter. In an initial state, the catheterand the inner needle are exposed from a leading end of the housing, andthe catheter hub and the protector are housed in the housing.

With the above configuration, since the catheter hub has been housed inthe housing, an exposure length of the inner needle from the housing canbe shortened in comparison to the conventional technique. Accordingly,an entire length of the catheter assembly in the initial state, namely,a length from a base end of the housing to a leading end of the innerneedle can be made shorter than that of the conventional catheterassembly. Accordingly, excellent storage due to its compactness isacquired and a puncture operation is easily performed. Since theexposure length of the inner needle from the housing is short, theprotector may be also made to be short. Accordingly, an entire productlength even in a state where the protector has covered the needlepoint(a protecting function appearance state) is short. Therefore, a waste iscompact, and disposal is relatively easy to perform.

According to an exemplary embodiment, the above catheter assembly mayfurther include a locking mechanism preventing displacement of theprotector with respect to the housing in a state where the protector hascovered the needlepoint. A passage formed of a groove or a holeextending in the axial direction, may be provided on a wall portionincluded in the housing. The locking mechanism may have an engagingportion protruding in the passage, and an engaging protrusion providedto the protector and capable of engaging with the engaging portion. Withthis configuration, there is no need for a structure protruding inwardin the housing in order to engage the housing and the protector. Thus, aforward movement of the catheter hub in the housing is not hindered.Accordingly, a forward movement operation of the catheter can besmoothly performed.

According to an exemplary embodiment of the above catheter assembly, acoming-off prevention protrusion for preventing the engaging protrusionfrom coming off into the housing may be provided on the engagingprotrusion. With this configuration, even in a case where the housing isdeflected, engagement between the engaging portion and the engagingprotrusion is prevented from being released.

According to an exemplary embodiment of the above catheter assembly, anoperating portion for operating the catheter hub may be provided on thecatheter hub, and in the initial state, at least a part of the operatingportion may be exposed from the housing. With this configuration, theoperating portion exposed from the housing is touched so that thecatheter hub can be operated. Thus, a forward movement operation of thecatheter can be performed relatively easily.

According to an exemplary embodiment of the above catheter assembly, aslit extending in the axial direction and open on a leading end side ofthe housing may be provided on the housing, and at least the part of theoperating portion may be exposed on an outside of the housing throughthe slit. With this configuration, the operating portion can be exposedon the outside of the housing with a relatively simple structure.

According to an exemplary embodiment of the above catheter assembly, theslit may be provided so as to be shifted to one side in a left and rightdirection with respect to a center of the housing. With thisconfiguration, when a puncture is operated, the inner needle can beprevented from being exposed outside the housing through the slit.

According to an exemplary embodiment of the above catheter assembly, theoperating portion may have a tab exposed outside the housing, and acoupling portion coupling the tab and the catheter hub, and the couplingportion may have flexibility in order to allow the operating portion tofall to a side of the catheter hub. With this configuration, upon usinga dressing material in order to fix the catheter hub to skin of apatient, when the operating portion falls to the side of the catheterhub, it is easy to stick the dressing material without making theoperating portion an obstacle.

According to an exemplary embodiment of the above catheter assembly, thecoupling portion may have a pedestal configured to abut on an outersurface of the housing so as to be slidable, and the tab may be providedon the pedestal. With this configuration, upon performing a forwardmovement operation of the catheter hub, the housing supports thepedestal. Thus, deflection in the axial direction of the couplingportion can be inhibited or prevented, and a relatively stable operationcan be performed.

According to an exemplary embodiment of the above catheter assembly, theoperating portion may include a pair of wings mutually protruding inopposite directions from the catheter hub and having flexibility, andthe pair of wings may be folded, overlapped each other, and may protrudefrom the slit in the initial state, and may be expansible in a state ofseparation from the slit. With this configuration, since the pair ofwings functions as the operating portion in the initial state, there isno need for providing an exclusive operating portion to the catheterhub. Thus, a configuration can be simplified.

According to an exemplary embodiment of the above catheter assembly, inthe initial state, the operating portion may extend along the innerneedle and the catheter hub, a base end portion may be coupled to thecatheter hub, and a leading end portion may be exposed on a leading endside of the housing. With this configuration, a portion of the operatingportion that has been exposed on the leading end side of the housing istouched so that an operation with respect to the operating portion canbe performed. Thus, the same hand that grips the leading end side of thehousing upon a puncture can operate the operating portion. Accordingly,between upon a puncture and upon a forward movement operation of thecatheter, there is no need for shifting a hand that performs theoperation. Thus, excellent operability can be acquired.

According to an exemplary embodiment, the above catheter assembly mayfurther include a needle support portion configured to support the innerneedle through the catheter on a leading end side beyond the catheterhub. The needle support portion may be provided movable with respect tothe housing in order to change from a first state of supporting theinner needle to a second state of releasing the support of the innerneedle and allowing the catheter hub to pass. With this configuration,deflection of the inner needle upon a puncture is inhibited orprevented, and a relatively stable puncture can be performed.

According to an exemplary embodiment of the above catheter assembly, theneedle support portion may have a pair of support arms openable andcloseable, and a restraining portion capable of restraining the pair ofsupport arms in a closed state and releasing the restraint. With thisconfiguration, the pair of support arms can securely support the innerneedle upon a puncture. In addition, upon a forward movement of thecatheter hub, the pair of support arms opens so that the movement of thecatheter hub with respect to the housing can be securely allowed.

A catheter assembly is disclosed comprising: a catheter; a catheter hubfixed to a base end portion of the catheter; an inner needle having aneedlepoint, and inserted into the catheter so as to be separable; ahousing coupled to the inner needle; and a protector displaceable in anaxial direction in a range regulated with respect to the housing, andconfigured to cover at least the needlepoint of the inner needle inaccordance with evulsion of the inner needle from the catheter.

A catheter assembly is disclosed comprising: a housing; a catheter; acatheter hub disposed in the housing and fixed to a proximal end portionof the catheter; a needle having a needlepoint, and inserted into thecatheter so as to be separable; a protector displaceable in an axialdirection of the housing, and disposed in the housing, and configured tocover at least the needlepoint of the needle in accordance with evulsionof the needle from the catheter; a needle support portion configured tosupport the needle through the catheter on a distal end side anddistally of the catheter hub; the needle support portion being movablewith respect to the housing in order to change from a first state ofsupporting the needle to a second state of releasing the support of theneedle and allowing the catheter hub to pass; and wherein the needlesupport portion has a pair of support arms openable and closeable, and arestraining portion capable of restraining the pair of support arms in aclosed state and releasing a restraint of the pair of support arms.

A catheter assembly is disclosed comprising: a housing; a catheter; acatheter hub disposed in the housing and fixed to a proximal end portionof the catheter; a needle having a needlepoint, and inserted into thecatheter so as to be separable; a protector displaceable in an axialdirection of the housing, and disposed in the housing and configured tocover at least the needlepoint of the needle; a needle support portionconfigured to support the needle through the catheter on a distal endside and distally of the catheter hub; the needle support portion beingmovable with respect to the housing in order to change from a firststate of supporting the needle to a second state of releasing thesupport of the needle and allowing the catheter hub to pass; the needlesupport portion having a pair of support arms openable and closeable;and a restraining portion capable of restraining the pair of supportarms in a closed state and releasing a restraint of the pair of supportarms.

A catheter assembly is disclosed comprising: a housing; a catheter; acatheter hub disposed in the housing and fixed to a proximal end portionof the catheter; a needle having a needlepoint, and inserted into thecatheter so as to be separable; a protector displaceable in an axialdirection of the housing, and disposed in the housing and configured tocover at least the needlepoint of the needle; a needle support portionconfigured to support the needle through the catheter on a distal endside and distally of the catheter hub; the needle support portion havinga pair of support arms openable and closeable; and a restraining portioncapable of restraining the pair of support arms in a closed state andreleasing a restraint of the pair of support arms.

A catheter assembly is disclosed comprising: a catheter; a catheter hubfixed to a proximal end portion of the catheter; a needle having aneedlepoint, and inserted into the catheter so as to be separable; anelongated member coupled to the needle; a protector displaceable in anaxial direction in a range regulated with respect to the elongatedmember, and configured to cover at least the needlepoint of the needlein accordance with evulsion of the needle from the catheter; andwherein, in an initial state, the catheter and the needle are exposedfrom a distal end of the elongated member, and the elongated memberoverlaps the catheter hub and the protector.

A catheter assembly is disclosed comprising: a catheter; a catheter hubfixed to a proximal end portion of the catheter; a needle having aneedlepoint, and inserted into the catheter so as to be separable; anelongated member coupled to the needle; a protector displaceable in anaxial direction of the elongated member, and configured to cover atleast the needlepoint of the needle in accordance with evulsion of theneedle from the catheter; a needle support portion configured to supportthe needle through the catheter on a distal end side and distally of thecatheter hub; the needle support portion being movable with respect tothe elongated member in order to change from a first state of supportingthe needle to a second state of releasing the support of the needle andallowing the catheter hub to pass; the needle support portion having apair of support arms openable and closeable; a restraining portioncapable of restraining the pair of support arms in a closed state andreleasing a restraint of the pair of support arms; and wherein, in thefirst state, the catheter and the needle are exposed from a distal endof the elongated member, and the elongated member overlaps the catheterhub and the protector.

An assembly is disclosed comprising: an outer needle; a hub fixed to aproximal end portion of the outer needle; an inner needle having aneedlepoint, and inserted into the outer needle so as to be separable;an elongated member coupled to the inner needle; a protectordisplaceable in an axial direction of the elongated member, andconfigured to cover at least the needlepoint of the inner needle inaccordance with evulsion of the inner needle from the outer needle; andwherein, in an initial state, the outer needle and the inner needle areexposed from a distal end of the elongated member, and the elongatedmember overlaps the hub and the protector.

According to the catheter assembly of the present disclosure, the entireproduct length can be shortened in comparison to the conventionalcatheter assembly including a protector.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a catheter assembly according to a firstembodiment of the present disclosure.

FIG. 2 is an exploded perspective view of the catheter assemblyillustrated in FIG. 1.

FIG. 3A is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 1.

FIG. 3B is a partially enlarged view of FIG. 3A.

FIG. 4A is a perspective view of a catheter hub and a hub operatingportion (an initial shape).

FIG. 4B is a perspective view of the catheter hub and the hub operatingportion (a shape upon transformation).

FIG. 5A is a bottom view of the catheter assembly in an initial state.

FIG. 5B is a partially enlarged view of FIG. 5A.

FIG. 6 is a perspective view of the catheter assembly illustrated inFIG. 1 from the bottom side in a state where an engaging portion and anengaging protrusion have engaged with each other.

FIG. 7 is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 1 in a state where a protector has extended partwaythrough.

FIG. 8 is a perspective view of the catheter assembly illustrated inFIG. 1 in the state where a protector has extended partway through.

FIG. 9 is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 1 in a state where the catheter hub and theprotector have separated from each other.

FIG. 10 is a perspective view of the catheter assembly illustrated inFIG. 1 in the state where the catheter hub and the protector haveseparated from each other.

FIG. 11 is a perspective view of a catheter assembly according to asecond embodiment of the present disclosure.

FIG. 12 is an exploded perspective view of the catheter assemblyillustrated in FIG. 11.

FIG. 13 is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 11.

FIG. 14 is a partially omitted rear view of the catheter assemblyillustrated in FIG. 11.

FIG. 15 is a perspective view of the catheter assembly illustrated inFIG. 11 from the bottom side in a state where a first engaging portionand a first engaging protrusion have engaged with each other and asecond engaging portion and a second engaging protrusion have engagedwith each other.

FIG. 16A is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 11 in a state where a catheter hub has moved forwardpartway through.

FIG. 16B is a perspective view of the catheter assembly illustrated inFIG. 11 in the state where a catheter hub has moved forward partwaythrough.

FIG. 17A is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 11 in a state where a protector has maximallyextended.

FIG. 17B is a perspective view of the catheter assembly illustrated inFIG. 11 in the state where a protector has maximally extended.

FIG. 18 is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 11 in a state where the catheter hub and theprotector have separated from each other.

FIG. 19 is a perspective view of a catheter assembly according to athird embodiment of the present disclosure.

FIG. 20 is an exploded perspective view of the catheter assemblyillustrated in FIG. 19.

FIG. 21 is a partially omitted longitudinal-sectional view of thecatheter assembly illustrated in FIG. 19.

FIG. 22A is a perspective view of a coupling state between a catheterhub and a hub operating portion.

FIG. 22B is a perspective view of a separating state between thecatheter hub and the hub operating portion.

FIG. 23 is a cross-sectional view taken along line XXIII-XXIII of FIG.21.

FIG. 24A is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 19 in a state where the hub operating portion hasmoved forward and slightly.

FIG. 24B is a perspective view of a part of the catheter assembly in thestate of FIG. 24A.

FIG. 25 is a longitudinal-sectional view of a state where the huboperating portion has further moved forward from the state of FIG. 24A.

FIG. 26 is a longitudinal-sectional view of a state where the huboperating portion has further moved forward from the state of FIG. 25and a protector has maximally extended.

FIG. 27 is a longitudinal-sectional view of the catheter assemblyillustrated in FIG. 19 in a state where a catheter member and theprotector have separated from each other.

DETAILED DESCRIPTION

Preferred embodiments regarding a catheter assembly according to thepresent disclosure, will be given and described below with reference tothe drawings.

FIG. 1 is a perspective view of a catheter assembly 10A according to afirst embodiment of the present disclosure. FIG. 2 is an explodedperspective view of the catheter assembly 10A. FIG. 3A is alongitudinal-sectional view of the catheter assembly 10A. FIG. 3B is apartially enlarged view of FIG. 3A.

The catheter assembly 10A can include a tubular catheter 12 functioningas an outer needle, a catheter hub 14 coupled to the side of a base end(i.e., proximal end) of the catheter 12, a tubular inner needle 16having a sharp needlepoint 17 on a leading end (i.e., distal end) andinsertable into the inside of the catheter 12, a housing 18 coupled tothe inner needle 16 and serving as a needle hub, and a protector 20 thatcovers the needlepoint 17 of the inner needle 16 upon evulsion of theinner needle 16.

With the catheter assembly 10A, a user (for example, a medical doctor ora nurse) grips and operates the housing 18 so that a leading end portionof the housing 18 can puncture a blood vessel of a patient. The catheterassembly 10A has a double tubular structure in which the inner needle 16has been inserted into the catheter 12 and the inner needle 16 hasprotruded from a leading end of the catheter 12 by a predeterminedlength in an initial state before use (before a puncture to thepatient). In the initial state of the catheter assembly 10A, thecatheter hub 14 and the housing 18 have been coupled through theprotector 20.

The catheter assembly 10A in the initial state can include one assemblyhaving the double tubular structure of the catheter 12 and the innerneedle 16, the catheter hub 14, the protector 20, and the housing 18combined, and is integrally operable.

The catheter 12 is a tubular member that has been formed so as to have apredetermined length, with a small diameter and flexibility. A resinmaterial and, in particular, a soft resin material are preferable asexamples of a constituent material of the catheter 12. In this case, forexample, the material of the catheter 12, can include fluororesins, suchas polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylenecopolymer (ETFE), and perfluoroalkoxy fluoropolymer (PFA), olefinresins, such as polyethylene and polypropylene, or a mixture of thefluororesins, polyurethane, polyester, polyamide, polyether nylon resin,and a mixture of the olefin resin and ethylene-vinyl acetate copolymer.The catheter 12 may include a resin having transparency so that theentire or partial inside can be visually ascertained.

The catheter hub 14 is coupled and fixed to the base end of the catheter12. A flange portion 22 protruding outward, extending in acircumferential direction, and serving as a male screw, is provided on abase end of the catheter hub 14.

The catheter hub 14 is provided with a hub operating portion 24 foroperating the catheter hub 14. The hub operating portion 24 has beenintegrally formed with respect to the catheter hub 14. The hub operatingportion 24 may be constituted as a component separated from the catheterhub 14, and may be attachable to and detachable from the catheter hub 14

As illustrated in FIG. 1, in the initial state, at least a part of thehub operating portion 24 is exposed from the housing 18. The huboperating portion 24 can include a tab 26 exposed outside the housing18, and a coupling portion 27 coupling the tab 26 and the catheter hub14. The tab 26 protrudes upward from the coupling portion 27. The usertouches and grips or presses the tab 26 so that the catheter hub 14 canbe operated in an axial direction.

As illustrated in FIG. 4A, the coupling portion 27 has a pedestal 28 onwhich the tab 26 is provided, and a thin-walled portion 29 providedbetween the pedestal 28 and the catheter hub 14. The coupling portion 27has a shape that bends so as to be lateral, substantially U-shaped as awhole in a natural state in which no external force acts (FIG. 4A). Thepedestal 28 abuts on an outer surface of the housing 18 (an uppersurface in FIG. 1) and is slidable in an axial direction of the housing18.

A thickness T2 of the thin-walled portion 29 is thinner than a thicknessT1 of the pedestal 28. A length L1 in an axial direction of the couplingportion 27 is larger than the thickness T2 of the thin-walled portion29. Accordingly, the coupling portion 27 barely deforms in an axialdirection of the catheter hub 14, but easily deforms at a part of thethin-walled portion 29 in a direction perpendicular to the axialdirection. As illustrated in FIG. 4B, the coupling portion 27 hasflexibility so that the hub operating portion 24 falls to the side ofthe catheter hub 14.

Hereinafter, a member including the catheter 12, the catheter hub 14,and the hub operating portion 24, will be referred to as a “cathetermember 25”.

Upon the use of the catheter assembly 10A, the catheter hub 14 isexposed on skin of the patient, stuck, and detained on the skin with adressing material or a tape in a state where the catheter 12 haspunctured the blood vessel. The above catheter hub 14 preferably caninclude a material harder than the catheter 12. Examples of theconstituent material of the catheter hub 14 that can be preferably usedinclude, but are not particularly limited to, thermoplastic resins, suchas polypropylene, polycarbonate, polyamide, polysulfone, polyarylate,and methacrylate-butylene-styrene copolymer.

As illustrated in FIG. 3B, according to the present embodiment, ahemostasis valve 30 having a valve portion 30 a including a slit formedon the valve portion 30 a, a seal member 32 disposed on the side of abase end of the hemostasis valve 30, and a tubular plug 34 capable ofpassing through the valve portion 30 a of the hemostasis valve 30 inaccordance with a movement in a leading end direction, are disposedinside the catheter hub 14. A gap through which air can pass is formedbetween the hemostasis valve 30 and an inner circumferential surface ofthe catheter hub 14. The seal member 32 is an annular member including amaterial that allows gas to pass through the seal member 32 and helpprevent liquid from passing through the seal member 32 (for example, aporous body).

When blood flows into the catheter hub 14 through an intra-cavity of thecatheter 12 in accordance with the puncture of the catheter 12 to theblood vessel, air that has been present on the leading end side in thecatheter hub 14 passes through the seal member 32 and then discharges tothe base end side in the catheter hub 14. However, the hemostasis valve30 and the seal member 32 can prevent the blood from flowing to the baseend side of the catheter hub 14.

A leading end of the plug 34 is positioned on the base end side beyondthe valve portion 30 a of the hemostasis valve 30 and the slit of thevalve portion 30 a is closed at an initial position illustrated in FIG.3B (a position before a connector of a transfusion tube is coupled).When the plug 34 moves in the leading end direction in accordance withcoupling between the catheter hub 14 and the connector of thetransfusion tube, the plug 34 passes through the valve portion 30 a ofthe hemostasis valve 30 so that the leading end side and the base endside of the intra-cavity of the catheter hub 14 communicate with eachother. Accordingly, a state where a transfusion can be supplied from atransfusion line to the blood vessel through the catheter member 25 isformed.

The inner needle 16 is a tubular member having rigidity capable ofpuncturing the skin of the patient in FIGS. 1 and 2. In accordance withan exemplary embodiment, the inner needle 16 is formed sufficientlylonger than the catheter 12. In the initial state of the catheterassembly 10A, the needlepoint 17 protrudes from a leading end opening ofthe catheter 12 by a predetermined length. In addition, in the initialstate, the inner needle 16 has a midway part in the longitudinaldirection inserted into the inside of the catheter hub 14, and has theside of the base end held inside the housing 18.

Examples of a constituent material of the inner needle 16 can include,for example, metal materials, such as stainless steel, aluminum or analuminum alloy, titanium or a titanium alloy.

The housing 18 can include a hollow housing main body 36 included in ashell to be gripped by the user, and a hollow inner needle holdingmember 38 to be fit into the inside on the base end side of the housingmain body 36. The housing main body 36 is a cylindrical member that hasa hollow portion including predetermined capacity and is formed so as tobe slender. The housing main body 36 is formed so as to be appropriatein size (thickness, length) in order to be easily gripped and operatedby the user upon the use of the catheter assembly 10A.

In the initial state of the catheter assembly 10A, the catheter 12 andthe inner needle 16 are exposed from the leading end of the housing 18,and the catheter hub 14 and the protector 20 are housed in the housing18. As a result, the leading end of the housing 18 extends to a midwayof the catheter 12. According to the present embodiment, a position ofthe base end of the catheter hub 14 is positioned on the base end sidebeyond a position of the center in the axial direction of the housing18, and the leading end of the housing 18 is positioned on the leadingend side beyond a position of the center in a longitudinal direction ofthe catheter 12.

As illustrated in FIGS. 1 and 2, the housing main body 36 can include aslit 40 extending in the axial direction of the housing 18 and open onthe leading end side of the housing 18, formed thereon. In the initialstate of the catheter assembly 10A, the part of the hub operatingportion 24 (the pedestal 28 and the tab 26 in the illustrated example)is exposed outside the housing 18 through the slit 40. The slit 40 isprovided so as to be shifted to one side in a left and right directionwith respect to the center in the left and right direction of thehousing 18. Accordingly, in plan view, the slit 40 and the inner needle16 are mutually shifted in the left and right direction, and the housing18 covers right above the inner needle 16.

As illustrated in FIG. 3A, the inner needle holding member 38 is fit andfixed to the base end side of the housing main body 36, and fixes andholds a base end portion of the inner needle 16. A filter 41 capable ofpreventing liquid and allowing gas to pass through the filter 41 isdisposed on the inside of a portion on the base end side of the innerneedle holding member 38. A flashback chamber 42 is formed ahead of thefilter 41. When the inner needle 16 and the catheter 12 puncture thepatient, the blood flows into the flashback chamber 42 through the innerneedle 16. The user can determine whether the puncture of the innerneedle 16 and the catheter 12 has been appropriately performed, due tothe flow of the blood into the flashback chamber 42.

The protector 20 houses the inner needle 16 so as to cover theneedlepoint 17 of the inner needle 16 upon evulsion of the inner needle16 from the catheter 12. As illustrated in FIGS. 2 and 3B, the protector20 has an inner tube 44 that fits to the base end of the catheter hub 14so as to be releasable, an outer tube 46 that can include the inner tube44 disposed inside and is relatively displaceable in the axis linedirection in a range regulated with respect to the inner tube 44, and anipple 48 that can include the outer tube 46 inserted into the insideand is slidable in the axial direction with respect to the outer tube46. Upon an evulsion operation of the inner needle 16 from the catheter12, the protector 20 extends so as to cover an entire length of theinner needle 16 (refer to FIG. 9).

The inner tube 44 functions to cover the needlepoint 17 of the innerneedle 16 in accordance with the evulsion of the inner needle 16 fromthe catheter 12. The inner tube 44 has a shutter housing portion 50housing a shutter member 49 (refer to FIG. 3B), arms 51 integrallyprovided on both of the left and right sides of the shutter housingportion 50 (refer to FIG. 2), a leading end cylindrical portion 52protruding from the shutter housing portion 50 to the leading end side,and a base end cylindrical portion 53 protruding from the shutterhousing portion 50 to the base end side. The inner tube 44 can includean insertion hole 44 a that passes through in the axial direction andinto which the inner needle 16 can be inserted inside (refer to FIG.3B).

The shutter member 49 is an elastic member formed by bending aplate-like member to be V-shaped. In a state where an apex has faced theside of a leading end of the inner tube 44, the shutter member 49 isdisposed in the shutter housing portion 50. In the initial state of thecatheter assembly 10A, the shutter member 49 is elastically compressedand deformed by pressure from a side surface of the inner needle 16 soas to be in a compact and closed state.

As illustrated in FIG. 2, the leading end cylindrical portion 52 iscylindrical. In a state where the catheter hub 14 and the inner tube 44have engaged (coupled) with each other, the leading end cylindricalportion 52 fits into the base end of the catheter hub 14. A hollowportion of the leading end cylindrical portion 52 and a hollow portionof the base end cylindrical portion 53 are provided on the same straightline, and communicate with each other through an internal space of theshutter housing portion 50.

As illustrated in FIG. 3B, the inner tube 44 can include a stopper 54fitting to the outer tube 46 so as to be releasable, provided thereon.The stopper 54 is displaceable between an engaging position at which thestopper 54 can engage with the outer tube 46 disposed outside the innertube 44 (refer to FIG. 3B) and a releasing position that is positionedinside the inner tube 44 beyond the engaging position and at which theengagement with the outer tube 46 is released and the stopper 54 entersthe inside of the hollow portion of the base end cylindrical portion 53(refer to FIG. 9).

In a state where the needlepoint 17 of the inner needle 16 has beenpositioned on the leading end side beyond the stopper 54, the stopper 54is pressed outward by the inner needle 16 and engages with the outertube 46 so that the outer tube 46 is prevented from moving backward withrespect to the inner tube 44. Meanwhile, when the needlepoint 17 of theinner needle 16 moves to the base end side beyond the stopper 54, thestopper 54 is displaced in an inward direction and the engagement withthe outer tube 46 is released. Thus, the outer tube 46 becomes movablebackward with respect to the inner tube 44.

In FIG. 2, the arms 51 engage with the base end of the catheter hub 14from the outside so as to be releasable. According to the presentembodiment, the arms 51 are provided so as to have a pair on left andright side surfaces of the shutter housing portion 50. Each of the arms51 is elastically deformable in the left and right direction. A pawl 51a (refer to FIG. 10) capable of engaging with the flange portion 22 ofthe catheter hub 14, is provided on the inside of a leading end of eachof the arms 51. The leading end side of each of the arms 51 inclines soas to expand outward in the leading end direction, in a natural statewhere no external force acts.

As illustrated in FIGS. 2 and 3B, the outer tube 46 has an arm housingportion 56 capable of housing the arms 51 and a cylindrical portion 57protruding from the side of a base end of the arm housing portion 56.The arm housing portion 56 can be formed so as to be box shaped havingan upper portion and a leading end portion both open. In the initialstate of the catheter assembly 10A, the arm housing portion 56 caninclude the base end of the catheter hub 14 and the side of the leadingend of the inner tube 44 (the pair of arms 51 and the shutter housingportion 50) disposed inside.

As illustrated in FIG. 3B, the base end cylindrical portion 53 of theinner tube 44 is inserted into the cylindrical portion 57 of the outertube 46. Long-hole slits 58 passing through the inside and the outsideof the cylindrical portion 57 are provided in an axis line direction ofthe cylindrical portion 57 so as to have a pair on an upper portion anda lower portion of a part close to a leading end of the cylindricalportion 57. Each protruding portion 55 provided on the inner tube 44 isinserted into each of the slits 58.

In accordance with an exemplary embodiment, first and second outwardprotrusions 60 and 61 protruding outward and extending in thecircumferential direction, can be provided at an interval in the axialdirection on an outer surface of a base end of the cylindrical portion57. An annular groove 62 is formed between the first outward protrusion60 and the second outward protrusion 61.

The nipple 48 has an intra-cavity capable of housing the cylindricalportion 57 of the outer tube 46. The nipple 48 is assembled to the outertube 46 so as to be relatively slidable. As illustrated in FIG. 2, aninner hook 64 protruding inward and extending in the circumferentialdirection, is provided on an inner surface of a leading end of thenipple 48. The inner hook 64 is capable of engaging with the annulargroove 62 provided on the outer tube 46 (refer to FIG. 7). A state wherethe inner hook 64 has engaged with the annular groove 62, helps preventa relative movement in the axial direction between the outer tube 46 andthe nipple 48. Accordingly, the annular groove 62 and the inner hook 64are included in a first locking mechanism 66 that prevents the relativemovement in the axial direction between the outer tube 46 and the nipple48.

An outer surface of a base end portion of the nipple 48 can include anengaging protrusion 67 protruding outward (downward in the illustratedexample) provided thereon (refer to FIGS. 3A and 6).

FIG. 5A is a bottom view of the catheter assembly 10A in the initialstate. As illustrated in FIG. 5A, a lower surface of the housing 18 caninclude a passage 68 extending in the axial direction and allowingdisplacement in the axial direction of the engaging protrusion 67provided on the nipple 48, and an engaging portion 70 disposed on theleading end side of the passage 68, provided thereon. In the initialstate, the engaging protrusion 67 is positioned in proximity to a baseend of the passage 68. According to the present embodiment, the passage68 is a hole passing through the inside and the outside of the housingmain body 36, but may be a groove provided on an inner surface of thehousing main body 36.

FIG. 5B is an enlarged view of the engaging portion 70 and the peripheryof the engaging portion 70. The engaging portion 70 has a pair of pawls71 protruding into the passage 68. The pair of pawls 71 include a pairof engaging arms 72 extending in a base end direction of the housing 18.A slit long hole 73 extending in the axial direction of the outer tube46 is provided on each of the left and right outsides of the pair ofengaging arms 72. Accordingly, the pair of engaging arms 72 iselastically deformable in directions in which the pair of engaging arms72 comes close to and separates from each other. The engaging portion 70including the above configuration and the engaging protrusion 67provided on the nipple 48 are capable of engaging with each other.

As illustrated in FIG. 6, when the protector 20 (the nipple 48 of theprotector 20) moves to a predetermined position with respect to thehousing 18, the engaging portion 70 and the engaging protrusion 67engage with each other. Specifically, the pawls 71 provided on the pairof engaging arms 72 hook on both sides of a base end of a columnarportion 67 a of the engaging protrusion 67. In a state where theengaging portion 70 and the engaging protrusion 67 have engaged witheach other, the movement in the axial direction of the nipple 48 withrespect to the housing 18 is prevented. Therefore, the nipple 48 isprevented from coming off the housing 18. In addition, the nipple 48 isprevented from moving backward in the housing 18. In this manner, asecond locking mechanism 74 for preventing displacement of the protector20 with respect to the housing 18 in a state where the protector 20 hascovered the needlepoint 17 can include the engaging portion 70 and theengaging protrusion 67.

As illustrated in FIG. 6, the engaging protrusion 67 preferably caninclude a coming-off prevention protrusion 67 b for preventing theengaging protrusion 67 from coming off into the housing 18. Thecoming-off prevention protrusion 67 b protrudes from the columnarportion 67 a in a width direction, and is capable of engaging with theouter surface of the housing 18.

As illustrated in FIG. 6, portions on both sides of the passage 68 arepreferably present outward beyond the engaging protrusion 67 in thehousing 18. Specifically, in FIG. 6, the portions on both sides of thepassage 68 are protrusions 75 protruding to the outside of the housing18 and extending in the axial direction of the housing 18. The aboveprotrusions 75 are provided so that the engaging protrusion 67 can beprevented from touching the skin of the patient.

Examples of a constituent material of the above housing 18 and each ofthe above members in the protector 20 (the inner needle holding member38, the inner tube 44, the outer tube 46, the nipple 48) that can beapplied include, but are not particularly limited, the materials givenin the descriptions of the catheter hub 14. In this case, all of themembers may be formed of the same material. Each of the members may beformed of a different material.

The catheter assembly 10A according to the first embodiment is basicallyconstituted as described above. Functions and effects of the catheterassembly 10A will be described below.

As illustrated in FIG. 3A, the catheter assembly 10A in the initialstate is in a state to be described below. The inner needle 16 has beeninserted into the catheter 12 and the needlepoint 17 has protruded fromthe leading end of the catheter 12 by the predetermined length. Theleading end cylindrical portion 52 of the inner tube 44 has beeninserted into the base end of the catheter hub 14. The outer tube 46 hasmaximally moved to the leading end side in a range movable with respectto the inner tube 44. The catheter 12 and the inner needle 16 have beenexposed from the leading end of the housing 18, and the catheter hub 14and the protector 20 have been housed in the housing 18. The pair ofarms 51 provided on the inner tube 44 (refer to FIG. 2) is positioned inthe arm housing portion 56 of the outer tube 46 so as to be in a closedstate. The pair of arms 51 that has been closed has engaged with theflange portion 22 of the catheter hub 14 so that the catheter hub 14 andthe protector 20 including the inner tube 44 have been prevented fromseparating from each other. The needlepoint 17 of the inner needle 16has been positioned on the leading end side beyond the stopper 54. Thestopper 54 has protruded outward beyond the base end cylindrical portion53 of the inner tube 44 and has engaged with the outer tube 46. Thus,the outer tube 46 has been prevented from moving in the base enddirection with respect to the inner tube 44. Furthermore, the nipple 48has been maximally inserted into the housing 18. The cylindrical portion57 of the outer tube 46 has been maximally inserted into the nipple 48.

In the use of the catheter assembly 10A, a user (for example, a medicaldoctor or a nurse) grips the housing 18 and punctures a blood vessel ofa patient with the catheter 12 and the inner needle 16. After thepuncture, a finger hooks the tab 26 of the hub operating portion 24protruding from the housing 18, and presses the hub operating portion 24in the leading end direction. Accordingly, the catheter hub 14 and thecatheter 12 that have been coupled to the hub operating portion 24, movein the leading end direction with respect to the housing 18. Thus, aninsertion length of the catheter 12 into the blood vessel increases.Meanwhile, the protector 20 coupled to the catheter hub 14 also movesforward in the housing 18 in accordance with the forward movement of thehub operating portion 24.

When the catheter 12 has been inserted into the blood vessel by apredetermined length, next, the housing 18 is pulled in the base enddirection with respect to the catheter member 25. Accordingly, the innerneedle 16 moves in the base end direction in the catheter 12, thecatheter hub 14, and the protector 20. In this case, the protector 20 isin a state where the protector 20 has not been displaced with respect tothe catheter member 25 (a movement stopping state) until the innerneedle 16 moves backward by a predetermined amount. Accordingly, theprotector 20 extends in accordance with a backward movement of thehousing 18. During a process during which the protector 20 extends, theinner needle 16 is evulsed from the catheter 12.

During the process during which the protector 20 extends, the outer tube46 relatively moves to the side of the leading end of the nipple 48, andthe nipple 48 also relatively moves to the side of the leading end ofthe housing 18. In accordance with the extension of the protector 20, asillustrated in FIG. 7, the engaging portion 70 provided to the housing18 and the engaging protrusion 67 provided at the base end of the nipple48 engage with each other. In addition, the annular groove 62 providedat a base end of the outer tube 46 and the inner hook 64 provided at theleading end of the nipple 48 engage with each other. FIG. 8 is aperspective view of the periphery of the protector 20 in this case. Instates of FIGS. 7 and 8, a function of the first locking mechanism 66prevents the movements in the axial direction of the outer tube 46 andthe nipple 48. In addition, a function of the second locking mechanism74 prevents the movements in the axial direction of the nipple 48 andthe housing 18.

Meanwhile, during a process during which the housing 18 moves backwardwith respect to the catheter member 25, the inner needle 16 also movesbackward with respect to the inner tube 44. Then, when the needlepoint17 of the inner needle 16 (refer to FIG. 2) moves to the base end sidebeyond the shutter member 49 disposed in the inner tube 44, the shuttermember 49, in which expansion has been regulated by the pressure fromthe inner needle 16, expands in the shutter housing portion 50 due toelastic restoring force. As a result, a movement path of the innerneedle 16 in the inner tube 44 can be prevented. Thus, the needlepoint17 of the inner needle 16 can be prevented from protruding again fromthe leading end of the inner tube 44. Note that, at this point in timeat which the needlepoint 17 has moved to the base end side beyond theshutter member 49, the arms 51 provided to the inner tube 44 have beenstill closed. The engagement between the inner tube 44 and the catheterhub 14 has been retained.

After the engaging portion 70 and the engaging protrusion 67 haveengaged with each other and the first and second outward protrusions 60and 61 and the inner hook 64 have engaged with each other, theneedlepoint 17 of the inner needle 16 moves to the base end side beyondthe stopper 54 provided to the inner tube 44 (refer to FIG. 7).Accordingly, due to elastic restoring force, the stopper 54 is displacedin an inward direction of the inner tube 44 or at least becomesdisplaceable in the inward direction of the inner tube 44. From thisstate, when the housing 18 further operates and moves in the base enddirection, the outer tube 46 is displaced in the base end direction withrespect to the inner tube 44. A state where the protector 20 hasmaximally extended can be acquired. Accordingly, the arms 51 expand sothat the inner tube 44 separates from the catheter hub 14 (refer toFIGS. 9 and 10).

Specifically, due to the displacement of the outer tube 46 in the baseend direction with respect to the inner tube 44, when the arms 51protrude from the arm housing portion 56 in the leading end direction,the expansion regulation of the arm housing portion 56 with respect tothe arms 51 is released. As a result, the arms 51 are actively displacedin an outward direction due to elastic restoring force. Accordingly, theengagement between the arms 51 provided to the inner tube 44 and theflange portion 22 provided to the catheter hub 14 is released. Thus, inaccordance with a movement of the housing 18 in the base end direction,the inner tube 44 separates from the catheter hub 14. That is, thecatheter hub 14 and the protector 20 separate from each other. A statewhere only the catheter member 25 out of the catheter assembly 10A hasbeen detained on the side of the patient, can be acquired.

Meanwhile, after the inner needle 16 has been evulsed from the catheter12, the catheter hub 14 is fixed to the patient with a dressing materialor a tape. A connector of a transfusion tube, not illustrated, iscoupled to the side of the base end of the catheter hub 14, and supplyof a transfusion material (a medical fluid) to the patient through thetransfusion tube is performed.

As described above, in the catheter assembly 10A according to thepresent embodiment, in the initial state, the catheter hub 14 has beenhoused in the housing 18 (refer to FIG. 3A). Accordingly, an exposurelength of the inner needle 16 from the housing 18 can be shortened incomparison to a conventional catheter assembly. Therefore, an entirelength of the catheter assembly 10A in the initial state, namely, alength from the base end of the housing 18 to a leading end of the innerneedle 16 can be made shorter than a conventional catheter assembly.Accordingly, excellent storage due to compactness is acquired and thepuncture operation is easily performed. Since the exposure length of theinner needle 16 from the housing 18 is short, the protector 20 may bealso made to be short. Accordingly, an entire product length even in astate where the protector 20 has covered the needlepoint 17 (aneedlepoint protecting state), is short. Therefore, a waste is compact,and disposal is relatively easy to perform.

According to the present embodiment, the passage 68 extending in theaxial direction is provided on a wall portion included in the housing18. In addition, the engaging portion 70 protruding in the passage 68and the engaging protrusion 67 provided to the protector 20 (the nipple48 of the protector 20) engage with each other so that the displacementof the protector 20 with respect to the housing 18 is prevented (referto FIG. 6). With this configuration, there is no need for a structureprotruding inward in the housing 18 in order to engage the housing 18and the protector 20. A forward movement of the catheter hub 14 is nothindered. Accordingly, a forward movement operation of the catheter 12can be performed relatively smoothly.

Specifically, the engaging protrusion 67 can include the coming-offprevention protrusion 67 b for preventing the engaging protrusion 67from coming off into the housing 18, provided thereon (refer to FIG. 6).Accordingly, even in a case where the housing 18 has been deflected, theengagement between the engaging portion 70 and the engaging protrusion67 is preferably prevented from being released.

According to the present embodiment, the portions on both sides of thepassage 68 have been present outward beyond the engaging protrusion 67in the housing 18 (refer to FIG. 6). Accordingly, the movement of theengaging protrusion 67 can be prevented from being hindered due tocontact of the engaging protrusion 67 with the patient. In particular,the portions on both sides of the passage 68 are protrusions 75protruding to the outside of the housing 18 and extending in the axialdirection of the housing 18. Thus, a lower wall of the housing 18 exceptthe protrusions 75 can be set so as to have an appropriate thickness.There is no need for thickening the entire lower wall of the housing 18.

According to the present embodiment, at least the part of the huboperating portion 24 is exposed from the housing 18 (refer to FIG. 1).Accordingly, coming in contact with the hub operating portion 24 exposedfrom the housing 18 can operate the catheter hub 14. Thus, the forwardmovement operation of the catheter 12 can be performed relativelyeasily. In particular, according to the present embodiment, the part ofthe hub operating portion 24 is exposed to the outside of the housing 18through the slit 40 provided on the housing 18. Thus, with a simplestructure, the hub operating portion 24 can be exposed to the outside ofthe housing 18.

According to the present embodiment, the slit 40 is provided so as to beshifted to the one side in the left and right direction with respect tothe center of the housing 18. Thus, when a puncture is operated, theinner needle 16 can be preferably prevented from being exposed to theoutside of the housing 18 through the slit 40.

According to the present embodiment, the coupling portion 27 hasflexibility so that the hub operating portion 24 falls to the side ofthe catheter hub 14. Accordingly, upon using a dressing material inorder to fix the catheter hub 14 to the skin of the patient, asillustrated in FIG. 4B, when the hub operating portion 24 falls to theside of the catheter hub 14, it is relatively easy to stick the dressingmaterial without making the hub operating portion 24 an obstacle.

In particular, the coupling portion 27 has the thin-walled portion 29.The length L1 in the axial direction of the coupling portion 27 islarger than the thickness T2 of the thin-walled portion 29. With thisconfiguration, since the coupling portion 27 is barely deflected in theaxial direction, a forward movement operation of the catheter hub 14 canbe stably performed. In addition, upon fixing the catheter hub 14 to thepatient, the coupling portion 27 is easily and laterally deformed(easily falls). Thus, fixing work of the catheter hub 14 can beperformed relatively smoothly.

The coupling portion 27 has the pedestal 28 that abuts on the outersurface of the housing 18 so as to be slidable. With this configuration,upon performing the forward movement operation of the catheter hub 14,the housing 18 supports the pedestal 28. Thus, the deflection in theaxial direction of the coupling portion 27 can be inhibited, and thestable operation can be performed.

FIG. 11 is a perspective view of a catheter assembly 10B according to asecond embodiment of the present disclosure. FIG. 12 is an explodedperspective view of the catheter assembly 10B. FIG. 13 is alongitudinal-sectional view of the catheter assembly 10B.

The catheter assembly 10B can include a tubular catheter 82 havingflexibility, a catheter hub 84 coupled to the side of a base end of thecatheter 82, a tubular inner needle 86 having a sharp needlepoint 87 ona leading end and insertable into the inside of the catheter 82, ahousing 88 serving as a needle hub coupled to the inner needle 86, and aprotector 90 that covers the needlepoint 87 of the inner needle 86 whenthe inner needle 86 is evulsed.

With the catheter assembly 10B, a user (for example, a medical doctor ora nurse) grips and operates the housing 88 so that a leading end portionof the housing 88 punctures a blood vessel of a patient. The catheterassembly 10B has a double tubular structure in which the inner needle 86has been inserted into the catheter 82 and the inner needle 86 hasprotruded from a leading end of the catheter 82 by a predeterminedlength in an initial state before use (before a puncture to thepatient). In the initial state of the catheter assembly 10B, thecatheter hub 84 and the housing 88 have been coupled through theprotector 90.

The catheter assembly 10B in the initial state can include one assemblyhaving the double tubular structure of the catheter 82 and the innerneedle 86, the catheter hub 84, the protector 90, and the housing 88combined, and is integrally operable.

The hollow cylindrical catheter hub 84 is coupled and fixed to the baseend of the catheter 82. A flange portion 92 protruding outward andextending in a circumferential direction is provided on a base end ofthe catheter hub 84.

The catheter hub 84 can include a pair of wings 94 that protrudes in aleft and right direction in a natural state, which is provided thereon.The wings 94 each have flexibility and are foldable so as to overlapwith each other. As illustrated in FIG. 12, according to the presentembodiment, each of the wings 94 can include a first thin-walled portion95 provided at a coupling part with the catheter hub 84 and a secondthin-walled portion 96 provided on the outside beyond the firstthin-walled portion 95. The first thin-walled portion 95 is provided soas to be groove-shaped on the side of a lower surface of each of thewings 94. The second thin-walled portion 96 is provided so as to begroove-shaped on the side of an upper surface of each of the wings 94.

With this configuration, the wings 94 easily fold upward at parts of thefirst thin-walled portions 95 and easily fold in a direction opposite tothe first thin-walled portions 95 at parts of the second thin-walledportions 96. As illustrated in FIG. 11, in the initial state of thecatheter assembly 10B, outer end portions of the wings 94 are exposedfrom the housing 88. The user touches and grips or presses the wings 94exposed from the housing 88 so that the catheter hub 84 can be operatedin an axial direction. That is, the pair of wings 94 functions as a huboperating portion for operating the catheter hub 84.

Hereinafter, a member including the catheter 82, the catheter hub 84,and the pair of wings 94 will be referred to as a “catheter member 98”.

As illustrated in FIG. 13, the inner needle 86 is formed sufficientlylonger than the catheter 82. In the initial state of the catheterassembly 10B, the needlepoint 87 protrudes from a leading end opening ofthe catheter 82 by a predetermined length. In addition, in the initialstate, the inner needle 86 has a midway part in the longitudinaldirection inserted into the inside of the catheter hub 84, and has theside of the base end held inside the housing 88.

As illustrated in FIGS. 12 and 13, the housing 88 can include a hollowhousing main body 100 included in a shell to be gripped by the user andan inner needle holding portion 101 provided on the base end side of thehousing main body 100. The inner needle holding portion 101 protrudesdownward from the center in the left and right direction on the side ofthe base end of the housing main body 100. A rail groove 102 extendingin the axial direction is provided on each of left and right innersurfaces of the housing main body 100.

In the initial state of the catheter assembly 10B, the catheter 82 andthe inner needle 86 are exposed from a leading end of the housing 88,and the catheter hub 84 and the protector 90 are housed in the housing88. As a result, the leading end of the housing 88 protrudes to a midwayof the catheter 82. According to the present embodiment, a position ofthe base end of the catheter hub 84 is positioned on the base end sidebeyond a position of the center in an axial direction of the housing 88,and the leading end of the housing 88 is positioned on the leading endside beyond a position of the center in a longitudinal direction of thecatheter 82.

As illustrated in FIGS. 11 to 13, a slit 103 that extends in the axialdirection of the housing 88 and is open on the side of the leading endof the housing 88 is formed in the housing 88 (specifically, the housingmain body 100). According to the present embodiment, the slit 103 isformed on an upper wall of the housing 88. In the initial state of thecatheter assembly 10B, the outer end portions of the wings 94 that havebeen folded and overlapped each other protrude upward from the housing88 through the slit 103.

The protector 90 houses the inner needle 86 in accordance with evulsionof the inner needle 86 from the catheter 82 so as to cover theneedlepoint 87 of the inner needle 86. As illustrated in FIGS. 12 and13, the protector 90 has an inner tube 104 fitting to the base end ofthe catheter hub 84 so as to be separable, and an outer tube 106 inwhich the inner tube 104 is disposed on the inside of the outer tube106, the outer tube 106 being relatively displaceable in the axialdirection in a range regulated with respect to the inner tube 104. Uponthe evulsion of the inner needle 86 from the catheter 82, the protector90 extends so as to cover an entire length of the inner needle 86 (referto FIG. 18).

The inner tube 104 functions to cover the needlepoint 87 of the innerneedle 86 in accordance with the evulsion of the inner needle 86 fromthe catheter 82. The inner tube 104 has a body portion 107 and a leadingend fitting portion 108 protruding from the body portion 107 in theleading end direction. An upper wall of the body portion 107 can includea cutout 109 extending in the axial direction, which is formed thereon.In the initial state, the inner tube 104 is positioned in the base endof the housing 88. The inner needle holding portion 101 of the housing88 is inserted into the cutout 109 of the body portion 107. Each of leftand right outer surfaces of the body portion 107 can include a railprotrusion 110 extending in the axial direction (refer to FIG. 12)provided on the body portion 107.

The leading end fitting portion 108 of the inner tube 104 is formed soas to have a taper shape that decreases in outer diameter as going inthe leading end direction. In the initial state, the leading end fittingportion 108 of the inner tube 104 fits into the base end of the catheterhub 84. The inner tube 104 and the catheter hub 84 are coupled due tofrictional resistance on a fitting surface.

The outer tube 106 is disposed between the inner tube 104 and thehousing 88. An upper wall of the outer tube 106 can include a cutout 112extending in the axial direction, formed thereon. In the initial state,the outer tube 106 is positioned in the base end of the housing 88 withthe inner tube 104. The inner needle holding portion 101 of the housing88 is inserted into the cutout 112.

A rail groove 117 extending in the axial direction is provided on eachof left and right inner surfaces of the outer tube 106. The railprotrusions 110 provided on the inner tube 104 are inserted into therail grooves 117 provided on the outer tube 106 (refer to FIG. 15). Eachof left and right outer surfaces of the outer tube 106 can include arail protrusion 118 extending in the axial direction provided thereon.The rail protrusions 118 provided on the outer tube 106 are insertedinto the rail grooves 102 provided on the housing main body 100 (referto FIG. 15).

As illustrated in FIG. 12, an outer surface of a base end portion of theinner tube 104 can include a first engaging protrusion 120 protrudingoutward (downward in the illustrated example) provided thereon.Meanwhile, as illustrated in FIGS. 14 and 15, the outer tube 106 caninclude a first passage 121 extending in the axial direction andallowing the first engaging protrusion 120 to be displaced in the axialdirection, and a first engaging portion 122 disposed on the side of alead end of the first passage 121, which are provided thereon. The firstpassage 121 extends to a base end surface of the outer tube 106. In theinitial state of the catheter assembly 10B, the first engagingprotrusion 120 is positioned at a base end of the first passage 121.According to the present embodiment, the first passage 121 is a holepassing through the inside and the outside of the outer tube 106, butmay be a groove provided on an inner surface of the outer tube 106.

The first engaging portion 122 has a pair of pawls 123 protruding intothe first passage 121. A slit long hole 124 extending in the axialdirection of the outer tube 106 is provided on each of the left andright outsides of the pair of pawls 123. Accordingly, the pair of pawls123 is elastically deformable in directions in which the pair of pawls123 comes close to and separates from each other. The first engagingportion 122 including the above configuration can mutually engage thefirst engaging protrusion 120 provided on the inner tube 104.

As illustrated in FIGS. 14 and 15, when the inner tube 104 relativelymoves forward to a predetermined position with respect to the outer tube106, the first engaging portion 122 and the first engaging protrusion120 engage with each other. Specifically, the first engaging protrusion120 gets over the pair of pawls 123 and the pair of pawls 123 hooks onboth sides of a base end of the first engaging protrusion 120. In astate where the first engaging portion 122 and the first engagingprotrusion 120 have engaged with each other, a relative movement in theaxial direction between the inner tube 104 and the outer tube 106 can beprevented. Therefore, the inner tube 104 can be prevented from comingoff the outer tube 106 to the leading end side. In addition, the innertube 104 can be prevented from moving backward into the outer tube 106.

In this manner, a first locking mechanism 126 for preventing relativedisplacement in the axial direction between the inner tube 104 and theouter tube 106 in a state where the protector 90 has covered theneedlepoint 87 can include the first engaging portion 122 and the firstengaging protrusion 120. Note that even in a case where bending stresshas acted on the inner tube 104 and the outer tube 106, engaging actionbetween the rail protrusions 110 provided on an outer surface of theinner tube 104 and the rail grooves 117 provided on the inner surface ofthe outer tube 106 helps prevent the first engaging protrusion 120 fromcoming off the first engaging portion 122. Accordingly, the function ofthe first locking mechanism 126 can be preferably retained.

As illustrated in FIGS. 14 and 15, an outer surface of a base endportion of the outer tube 106 can include a second engaging protrusion128 protruding outward (downward in the illustrated example) provided onthe outer surface of the base end portion of the outer tube 106.Meanwhile, the housing 88 (specifically, the housing main body 100) caninclude a second passage 129 extending in the axial direction andallowing displacement in the axial direction of the second engagingprotrusion 128 provided on the outer tube 106, and a second engagingportion 130 disposed on the side of a leading end of the second passage129, which are provided thereon. The second passage 129 extends to abase end surface of the housing 88. In the initial state of the catheterassembly 10B, the second engaging protrusion 128 is positioned at a baseend of the second passage 129. According to the present embodiment, thesecond passage 129 is a hole passing through the inside and the outsideof the housing 88, but may be a groove provided on an inner surface ofthe housing 88.

The second engaging portion 130 has a pair of pawls 131 protruding intothe second passage 129. A slit long hole 132 extending in the axialdirection of the housing 88 is provided on each of the left and rightoutsides of the pair of pawls 131. Accordingly, the pair of pawls 131 iselastically deformable in directions in which the pair of pawls 131comes close to and separates from each other. The second engagingportion 130 including the above configuration can mutually engage thesecond engaging protrusion 128 provided on the inner tube 104.

As illustrated in FIGS. 14 and 15, when the outer tube 106 relativelymoves forward to a predetermined position with respect to the housing88, the second engaging portion 130 and the second engaging protrusion128 engage with each other. Specifically, the second engaging protrusion128 gets over the pair of pawls 131 and the pair of pawls 131 hooks onboth sides of a base end of the second engaging protrusion 128. In astate where the second engaging portion 130 and the second engagingprotrusion 128 have engaged with each other, relative displacement inthe axial direction between the outer tube 106 and the housing 88 can beprevented. Therefore, the outer tube 106 can be prevented from comingoff the housing 88. In addition, the outer tube 106 can be preventedfrom moving backward into the housing 88.

In this manner, a second locking mechanism 134 for preventing therelative movement in the axial direction between the outer tube 106 andthe housing 88 in a state where the protector 90 has covered theneedlepoint 87 can include the second engaging portion 130 and thesecond engaging protrusion 128. Note that even in a case where bendingstress has acted on the outer tube 106 and the housing 88, engagingaction between the rail protrusions 118 provided on an outer surface ofthe outer tube 106 and the rail grooves 102 provided on the innersurface of the housing 88 prevents the second engaging protrusion 128from coming off the second engaging portion 130. Accordingly, thefunction of the second locking mechanism 134 can be preferably retained.

As illustrated in FIG. 14, the first locking mechanism 126 and thesecond locking mechanism 134 are disposed so as to be shifted to eachother in a circumferential direction.

As illustrated in FIGS. 11 to 13, the catheter assembly 10B further caninclude a needle support portion 136 in order to inhibit deflection ofthe inner needle 86 upon a puncture. The needle support portion 136supports the inner needle 86 through the catheter 82 on the leading endside beyond the catheter hub 84 in the initial state of the catheterassembly 10B. The needle support portion 136 can be movable with respectto the housing 88 in order to change from a first state of supportingthe inner needle 86 to a second state of releasing the support withrespect to the inner needle 86 and allowing the catheter hub 84 to pass.

According to the present embodiment, specifically, the needle supportportion 136 has a pair of support arms 138 openable and closeable and arestraining portion 140 capable of restraining the pair of support arms138 in a closed state and also releasing the restraint. Hereinafter, ina case where one and the other of the pair of support arms 138 aredistinguished from each other and described, the one will be indicatedas a “support arm 138 a” and the other will be indicated as a “supportarm 138 b”.

The pair of support arms 138 is rotatably coupled to the housing 88through a pair of support pins 141. In the present illustrated example,each of the pair of support pins 141 has an axis in an upper and lowerdirection. The pair of support arms 138 supported by the pair of supportpins 141 is openable and closeable in a left and right direction.

A coupling protruding portion 139 protruding in the base end directionis provided at a base end of each of the arms 138. Two supportprotruding portions 142 protruding in the leading end direction areprovided on each of the left and right sides of the leading end of thehousing 88. The coupling protruding portion 139 provided on each of thesupport arms 138 is disposed between the two support protruding portions142 apart from each other in the upper and lower direction and extendingin parallel on each of the left and right sides. The support pin 141 isinserted into the two support protruding portions 142 and the couplingprotruding portion 139.

Note that, according to a modification, one support protruding portion142 protruding in the leading end direction may be provided on each ofthe left and right sides of the leading end of the housing 88.Alternatively, according to another modification, two couplingprotruding portions 139 apart from each other in the upper and lowerdirection and extending in parallel may be provided at the base end ofeach of the support arms 138. One support protruding portion 142protruding in the leading end direction may be provided on each of theleft and right sides of the leading end of the housing 88.

In each of the support arms 138, a support groove 143 for holding theinner needle 86 in a state where the pair of support arms 138 has beenclosed is provided. In the state where the pair of support arms 138 hasbeen closed, the two support grooves 143 form a support hole 144 forsupporting the inner needle 86. The support hole 144 extends in theaxial direction of the housing 88, namely, in a direction in which theinner needle 86 extends in the initial state.

One of the support arms 138 has a bending engaging groove 145 a providedthereon and the other has a bending engaging groove 145 b providedthereon when viewed from the front side in the closed state. Theengaging grooves 145 a and 145 b pass through the support arms 138 a and138 b, respectively, in a longitudinal direction. One engaging groove145 a (hereinafter, referred to as a “first engaging groove 145 a”) andthe other engaging groove 145 b (hereinafter, referred to as a “secondengaging groove 145 b) mutually bend in opposite directions.Specifically, the first engaging groove 145 a bends downward and thesecond engaging groove 145 b bends upward.

The restraining portion 140 is disposed slidable with respect to thepair of support arms 138. The restraining portion 140 is pressed by thecatheter hub 84 in accordance with a forward movement of the catheterhub 84 so that the restraint with respect to the pair of the supportarms 138 is released.

Specifically, the restraining portion 140 has a first restrainingprotrusion 146 a engaging with the first engaging groove 145 a so as tobe slidable and a second restraining protrusion 146 b engaging with thesecond engaging groove 145 b so as to be slidable. In the presentillustrated example, the first restraining protrusion 146 a and thesecond restraining protrusion 146 b mutually protrude in oppositedirections so as to fit to shapes of the first engaging groove 145 a andthe second engaging groove 145 b provided on the pair of support arms138, respectively. When the restraining portion 140 is positioned at aninitial position (a backward position), the first restraining protrusion146 a and the second restraining protrusion 146 b of the restrainingportion 140 engage with the first engaging groove 145 a and the secondengaging groove 145 b of the pair of support arms 138, respectively.Accordingly, the pair of support arms 138 is restrained in the closedstate.

The second restraining protrusion 146 b separates from the secondengaging groove 145 b of the support arm 138 b in the leading enddirection in accordance with a movement of the restraining portion 140in the leading end direction. When the second restraining protrusion 146b separates from the second engaging groove 145 b, the restraint of therestraining portion 140 with respect to the pair of support arms 138 isreleased and the pair of support arms 138 becomes expansible. Note that,even after the second restraining protrusion 146 b has separated fromthe second engaging groove 145 b, engagement between the firstrestraining protrusion 146 a and the first engaging groove 145 a isretained so that the restraining portion 140 is held by the support arm138 a.

In a state where the second restraining protrusion 146 b has separatedfrom the second engaging groove 145 b, the second restraining protrusion146 b protrudes to the side opposite to the side on which the innerneedle 86 is present (refer to FIG. 16B). Accordingly, when the supportarm 138 a opens in a state where the inner needle 86 has bended to theside of the restraining portion 140, the inner needle 86 is preventedfrom being hooked on the second restraining protrusion 146 b. Note that,according to a modification, the second restraining protrusion 146 b mayprotrude to the side on which the inner needle 86 is present. In thiscase, a bending shape of the second engaging groove 145 b to be providedto the support arm 138 b, is formed so as to be in a direction in whichthe second restraining protrusion 146 b protrudes.

A base end of the restraining portion 140 can include a portion to bepressed 147 provided thereat. Upon a forward movement of the catheterhub 84 with respect to the housing 88, the leading end of the catheterhub 84 pressed the portion to be pressed 147 so that the restrainingportion 140 moves forward with respect to the pair of support arms 138.A surface of the portion to be pressed 147 facing the catheter hub 84can include a taper that inclines so as to be displaced outward in theleft and right direction as going in the base end direction, providedthereon.

Note that the respective members in the catheter assembly 10B accordingto the second embodiment, having the same terms as those in the catheterassembly 10A according to the first embodiment include the materialsexemplified as constituent materials of those of the catheter assembly10A.

The catheter assembly 10B according to the second embodiment isbasically constituted as described above. Functions and effects of thecatheter assembly 10B will be described below.

As illustrated in FIGS. 11 and 13, the catheter assembly 10B in theinitial state is in a state to be described below. The inner needle 86has been inserted into the catheter 82 and the needlepoint 87 hasprotruded from the leading end of the catheter 82 by the predeterminedlength. The leading end fitting portion 108 of the inner tube 104 hasbeen inserted into the base end of the catheter hub 84. The outer tube106 has maximally moved to the leading end side in a movable range withrespect to the inner tube 104. The catheter 82 and the inner needle 86have been exposed from the leading end of the housing 88, and thecatheter hub 84 and the protector 90 have been housed in the housing 88.The protector 90 is positioned on the base end side in the housing 88.The restraining portion 140 has been positioned at the backward positionin a movable range. The pair of support arms 138 has been restrained inthe closed state by the restraining portion 140. The inner needle 86 hasbeen held by the pair of support arms 138 in the closed state throughthe catheter 82.

In the use of the catheter assembly 10B, a user (for example, a medicaldoctor or a nurse) grips the housing 88 and punctures a blood vessel ofa patient with the catheter 82 and the inner needle 86. In this case,the inner needle 86 has been supported by a support hole 144 formedbetween the pair of support arms 138 that has been closed, through thecatheter 82, so that the deflection of the inner needle 86 is inhibitedupon the puncture. Accordingly, a stable puncture can be performed.

After the puncture, a finger hooks the pair of wings 94 protruding fromthe housing 88, and pressed the pair of wings 94 in the leading enddirection. Accordingly, the catheter hub 84 and the catheter 82 thathave been coupled to the pair of wings 94, move in the leading enddirection with respect to the housing 88. Thus, an insertion length ofthe catheter 82 into the blood vessel increases. Meanwhile, theprotector 90 coupled to the catheter hub 84 also moves forward in thehousing 88 in accordance with the forward movement operation of thewings 94.

As illustrated in FIGS. 16A and 16B, the catheter hub 84 presses therestraining portion 140 in the leading end direction in accordance withthe forward movement of the catheter hub 84. Accordingly, therestraining portion 140 moves in the leading end direction with respectto the pair of support arms 138, and the second restraining protrusion146 b separates from the second engaging groove 145 b. The secondrestraining protrusion 146 b separates from the second engaging groove145 b so that the restraint of the restraining portion 140 with respectto the pair of support arms 138 is released and the pair of support arms138 becomes expansible. After that, the pair of support arms 138 ispressed from the rear side by the catheter hub 84 and expands inaccordance with a further forward movement of the catheter hub 84.

After the catheter 82 has been inserted into the blood vessel by apredetermined length, the housing 88 is next pulled in the base enddirection in a state where a position of the catheter member 98 has beenheld. Accordingly, the inner needle 86 moves in the base end directionin the catheter 82, the catheter hub 84, and the protector 90. In thiscase, since the leading end fitting portion 108 of the inner tube 104 ofthe protector 90 and the catheter hub 84 have fitted to each other dueto predetermined fitting force, the protector 90 extends in accordancewith the backward movement of the housing 88. Specifically, the innertube 104 relatively moves to the side of a leading end of the outer tube106 and the outer tube 106 also relatively moves to the side of theleading end of the housing 88. After a while, a state where theprotector 90 has maximally extended is acquired (refer to FIGS. 17A and17B). During a process during which the protector 90 maximally extends,the inner needle 86 is evulsed from the catheter 82. In addition, theinner needle 86 is housed in the protector 90 with the needlepoint 87.

In a state where the protector 90 has maximally extended, as illustratedin FIGS. 14 and 15, a function of the first locking mechanism 126prevents the relative movement in the axial direction between the innertube 104 and the outer tube 106. In addition, a function of the secondlocking mechanism 134 prevents the relative movement in the axialdirection between the outer tube 106 and the housing 88.

Specifically, in the first locking mechanism 126, since the firstengaging protrusion 120 has been positioned at the maximum leading endposition of the first passage 121, the inner tube 104 cannot move anyfurther in the leading end direction with respect to the outer tube 106.In the first locking mechanism 126, since the first engaging protrusion120 and the first engaging portion 122 has engaged with each other, theinner tube 104 cannot move in the base end direction with respect to theouter tube 106.

In the second locking mechanism 134, since the second engagingprotrusion 128 has been positioned at the maximum leading end positionof the second passage 129, the outer tube 106 cannot move any further inthe leading end direction with respect to the housing 88. In the secondlocking mechanism 134, since the second engaging protrusion 128 and thesecond engaging portion 130 have engaged with each other, the outer tube106 cannot move in the base end direction with respect to the housing88.

During a process during which the catheter assembly 10B is transferredfrom a state in FIG. 16A to a state in FIG. 17A, the pair of supportarms 138 is pressed from the rear side by the catheter hub 84 so as toexpand and allow movements of the catheter hub 84 and the protector 90with respect to the housing 88 (refer to FIG. 17B). In this manner, theneedle support portion 136 supports the inner needle 86 in the initialstate and inhibits or prevents the deflection of the inner needle 86upon the puncture. Meanwhile, after the puncture, the pair of supportarms 138 opens so as to prevent interference with the catheter hub 84and the protector 90.

After the protector 90 has maximally extended, when the housing 88 isfurther pulled in the base end direction with respect to the cathetermember 98, as illustrated in FIG. 18, the fit between the catheter hub84 and the leading end fitting portion 108 of the inner tube 104 comesoff. Accordingly, a state where the protector 90 has completelyseparated from the catheter member 98 and only the catheter member 98out of the catheter assembly 10B has been detained on the side of thepatient, is acquired.

After the catheter member 98 and the protector 90 have separated fromeach other, the pair of wings 94 provided on the catheter hub 84 expandsin the left and right direction. The pair of wings 94 is fixed to skinof the patient with a tape or the like so as to fix the catheter hub 84.In accordance with an exemplary embodiment, a connector of a transfusiontube, not illustrated, can be coupled to the side of the base end of thecatheter hub 84, and supply of a transfusion material (a medical fluid)to the patient through the transfusion tube is performed.

As described above, the catheter assembly 10B according to the secondembodiment can include the catheter hub 84 housed in the housing 88 inthe initial state. Thus, as in the first embodiment, an entire productlength can be shortened in both of the initial state and the needlepointprotecting state due to the protector 90. According to the secondembodiment, other respective constituent portions shared with the firstembodiment acquire functions and effects similar to those according tothe first embodiment.

According to the second embodiment, since the pair of wings 94 functionsas the operating portion for the catheter hub 84 in the initial state,there is no need for providing an exclusive operating portion to thecatheter hub 84. Thus, the configuration can be simplified.

Furthermore, according to the second embodiment, the needle supportportion 136 for supporting the inner needle 86 through the catheter 82on the leading end side beyond the catheter hub 84, is provided. Theneedle support portion 136 is provided movable with respect to thehousing 88 in order to change from the first state of supporting theinner needle 86 to the second state of releasing the support of theinner needle 86 and allowing the catheter hub 84 to pass. With thisconfiguration, the deflection of the inner needle 86 upon a puncture isinhibited, and a stable puncture can be performed.

In particular, the needle support portion 136 can include the pair ofsupport arms 138 openable and closeable, and the restraining portion 140capable of restraining the pair of support arms 138 in the closed stateand releasing the restraint. With this configuration, the pair ofsupport arms 138 can securely support the inner needle 86 upon apuncture. In addition, upon the forward movement of the catheter hub 84,the pair of support arms 138 opens so that the movement of the catheterhub 84 with respect to the housing 88 can be securely allowed.

The restraining portion 140 is slidable with respect to the pair ofsupport arms 138. In accordance with a forward movement of the catheterhub 84, the restraining portion 140 is pressed by the catheter hub 84 sothat the restraint with respect to the pair of support arms 138 isreleased. With this configuration, the restraint with respect to thepair of support arms 138 is automatically released in response to theforward movement operation of the catheter hub 84. Thus, there is noneed for an independent release operation. Therefore, excellentoperability can be acquired.

Note that the hinge structure in which each of the support arms 138 iscoupled to the housing 88 so as to rotatable, is not limited to thestructure including the above support pin 141. For example, the pair ofsupport arms 138 and the housing 88 may be included in a structureintegrally formed through a thin-walled portion. In this case, thethin-walled portion functions as a bending portion so that the pair ofsupport arms 138 is rotatable with respect to the housing 88.

Instead of the configuration in which the pair of support arms 138 issupported so as to be rotatable by the pair of support pins 141perpendicular to the axial direction of the housing 88, the pair ofsupport arms 138 may be supported so as to be rotatable by a pair ofsupport pins parallel to the axial direction of the housing 88. Withthis configuration, the pair of support arms 138 is openable andcloseable in the left and right direction.

The configuration in which the pair of support arms 138 is openable andcloseable in the left and right direction, is not limited to theconfiguration including the hinge structure. For example, the pair ofsupport arms 138 may be slidable in a width direction of the housing 88(the left and right direction) so as to be openable and closeable.

In the above configuration, each of the support arms 138 can include thesupport groove 143 provided thereon, and the two support grooves 143form the support hole 144. Thus, a position of a contact surface betweenthe support arms 138 in the left and right direction is substantiallythe same as a position of the center of the inner needle 86 supported bythe support hole 144. Accordingly, in a case where predetermined forceor more acts on the inner needle 86 in the upper and lower direction,there is a possibility that the inner needle 86 comes off the pair ofsupport arms 138 that has been closed. Therefore, a configuration inwhich the position of a contact surface between the pair of support arms138 is shifted in the left and right direction with respect to thecenter of the inner needle 86 supported by the support hole 144, isprovided. Thus, even when force in the upper and lower direction acts onthe inner needle 86, the inner needle 86 barely comes off the pair ofsupport arms 138 that has been closed. An example of the aboveconfiguration is that at least a support groove having a depth largerthan an outer diameter of the catheter 82 is provided on only one of thepair of support arms 138, and the support groove and an inner surface ofthe other of the pair of support arms 138 form a support hole 144.

In the above configuration, the catheter hub 84 presses the restrainingportion 140 so that the restraint with respect to the pair of supportarms 138 is released. Instead of this type of configuration, the wings94 may press the restraining portion 140, and the restraint with respectto the pair of support arms 138 may be released. Alternatively, thecatheter assembly 10B may further include a guide wire G inserted intothe inner needle 86, and a guide wire operating portion 149 foroperating the guide wire G, the guide wire operating portion 149 beingcoupled to the guide wire G (refer to FIG. 13). In this case, the guidewire operating portion 149 may press the restraining portion 140 inaccordance with a forward movement of the guide wire operating portion149. Thus, the restraint with respect to the pair of support arms 138may be released.

FIG. 19 is a perspective view of a catheter assembly 10C according to athird embodiment of the present disclosure. FIG. 20 is an explodedperspective view of the catheter assembly 10C. FIG. 21 is a partiallyomitted longitudinal-sectional view of the catheter assembly 10C. Notethat, in the catheter assembly 10C according to the third embodiment,elements having functions and effects the same as or similar to those ofthe catheter assembly 10B according to the second embodiment, aredenoted with the same reference signs, and the duplicate descriptions ofthe element having functions and effects the same or similar to those ofthe catheter assembly 10B, and which are denoted with the same referencesigns will be omitted.

The catheter assembly 10C can include a tubular catheter 152 havingflexibility, a catheter hub 154 coupled to the side of a base end of thecatheter 152, a tubular inner needle 156 having a sharp needlepoint 157on a leading end and insertable into the inside of the catheter 152, ahousing 158 coupled to the inner needle 156, and a protector 90 thatcovers the needlepoint 157 of the inner needle 156 when the inner needle156 is evulsed.

A user (for example, a medical doctor or a nurse) grips and operates thehousing 158 so that a leading end portion of the catheter assembly 10Cpunctures a blood vessel of a patient. In accordance with an exemplaryembodiment, the catheter assembly 10C has a double tubular structure inwhich the inner needle 156 has been inserted into the catheter 152 andthe inner needle 156 has protruded from a leading end of the catheter152 by a predetermined length in an initial state before use (before apuncture to the patient). In the initial state of the catheter assembly10C, the side of a base end of the catheter hub 154 and the side of aleading end of the housing 158 have been coupled through a protector 90.

The catheter assembly 10C in the initial state can include one assemblyhaving the double tubular structure of the catheter 152 and the innerneedle 156, the catheter hub 154, the protector 90, and the housing 158combined, and is integrally operable.

The catheter 152 according to the third embodiment is longer than thecatheters 12 and 82 according to the first and second embodiments,respectively. The catheter 152 may be used as a catheter, for example, acentral venous catheter, a PICC, or a midline catheter, longer than aperipheral venous catheter in length. Note that the catheter 152 may beused as the peripheral venous catheter.

The hollow cylindrical catheter hub 154 is coupled and fixed to a baseend of the catheter 152. A flange portion 155 protruding outward andextending in a circumferential direction, is provided on a base end ofthe catheter hub 154.

The catheter hub 154 is provided with a hub operating portion 160 foroperating the catheter hub 154. In the initial state of the catheterassembly 10C, at least a part of the hub operating portion 160 has beenexposed from the housing 158. Specifically, in the initial state, thehub operating portion 160 extends along the inner needle 156 and thecatheter hub 154. In addition, a base end portion is coupled to thecatheter hub 154, and a leading end portion is exposed on the side ofthe leading end of the housing 158.

The hub operating portion 160 has a long main body portion 161 and a tab162 to be hooked by a finger, the tab 162 being provided at a leadingend of the main body portion 161. The tab 162 protrudes upward from theleading end of the main body portion 161.

The hub operating portion 160 is coupled to the catheter hub 154 so asto be rotatable. In the present illustrated example, a supportprotrusion 163 protruding outward is provided on an outer surface oneach of the left and right sides of the catheter hub 154. Each of thesupport protrusions 163 extends in an upper and lower direction.Meanwhile, a base end portion of the main body portion 161 can include apair of coupling pieces 164 each having a coupling groove 165 and facingeach other on the left and right sides, provided thereon.

As illustrated in FIG. 22A, each of the coupling grooves 165 can includea first groove 165 a for engagement and a second groove 165 b forseparation having a groove width narrower than the first groove 165 a,extending from the first groove 165 a in a base end direction, andreaching a base end surface of the coupling piece 164. In accordancewith an exemplary embodiment, the groove width W2 of the second grooves165 b can be slightly larger than a width W1 of the support protrusions163 (refer to FIG. 22B). Each of the support protrusions 163 provided tothe catheter hub 154 is inserted into each of the first grooves 165 aprovided to the hub operating portion 160. Accordingly, the huboperating portion 160 has the support protrusions 163 as axial portionsand is supported so as to be rotatable with respect to the catheter hub154. In the initial state, the hub operating portion 160 issubstantially parallel to the catheter 152 and the inner needle 156, andeach of the support protrusions 163 engages with each of the firstgrooves 165 a. Thus, the hub operating portion 160 is prevented fromseparating from the catheter hub 154.

As illustrated in FIG. 22B, since extending directions of the supportprotrusions 163 and the second grooves 165 b become the same at aposition at which the hub operating portion 160 is substantiallyperpendicular to an axial direction of the catheter hub 154, the huboperating portion 160 is separable from the catheter hub 154. Note thata constituent material of the hub operating portion 160 is notparticularly limited, and may be the same as a constituent material ofthe catheter hub 154 for example.

Hereinafter, a member including the catheter 152, the catheter hub 154,and the hub operating portion 160, will be referred to as a “cathetermember 168”.

As illustrated in FIG. 21, the inner needle 156 is formed sufficientlylonger than the catheter 152. In the initial state of the catheterassembly 10C, the needlepoint 157 protrudes from a leading end openingof the catheter 152 by a predetermined length. The inner needle 156according to the third embodiment is longer than the inner needles 16and 86 according to the first and second embodiments, respectively.

In the initial state of the catheter assembly 10C, the inner needle 156has a midway part in the longitudinal direction inserted into the insideof the catheter hub 154, and has the side of the base end held insidethe housing 158.

The housing 158 can include a hollow housing main body 170 included in ashell to be gripped by the user, and an inner needle holding portion 101provided on the base end side of the housing main body 170. The housingmain body 170 according to the third embodiment is longer than thehousing main body 36 according to the first and second embodiments.

In the initial state of the catheter assembly 10C, the catheter 152 andthe inner needle 156 are exposed from the leading end of the housing158, and the catheter hub 154 and the protector 90 are housed in thehousing 158. As a result, the leading end of the housing 158 protrudesto a midway of the catheter 152. According to the present embodiment, aposition of the base end of the catheter hub 154 is positioned on thebase end side beyond a position of the center in an axial direction ofthe housing 158, and the leading end of the housing 158 is positioned onthe leading end side beyond a position of the center in a longitudinaldirection of the catheter 152.

In the initial state of the catheter assembly 10C, most of the huboperating portion 160 is housed in the housing 158, and the leading endportion of the hub operating portion 160 (tab 162) is exposed on theleading end side beyond the leading end of the housing 158.

The protector 90 houses the inner needle 156 upon evulsion of the innerneedle 156 from the catheter 152 so as to cover the needlepoint 157 ofthe inner needle 156. The protector 90 according to the third embodimenthas a configuration similar to that of the protector 90 according to thesecond embodiment, and has an inner tube 104 and an outer tube 106. Inthe initial state, a leading end fitting portion 108 of the inner tube104 fits to the inside of the base end of the catheter hub 154. Upon anevulsion operation of the inner needle 156 from the catheter 152, theprotector 90 extends with the housing 158 so as to cover an entirelength of the inner needle 156 (refer to FIG. 26). Note that thecatheter assembly 10C also can include the first locking mechanism 126and the second locking mechanism 134 illustrated in FIG. 15.

As illustrated in FIGS. 19 to 21, the catheter assembly 10C further caninclude a needle support portion 172 in order to inhibit deflection ofthe inner needle 156 upon a puncture. The needle support portion 172supports the inner needle 156 through a catheter 152 on the leading endside beyond the catheter hub 154 in the initial state. The needlesupport portion 172 is provided movable with respect to the housing 158in order to change from a first state of supporting the inner needle 156to a second state of releasing the support with respect to the innerneedle 156 and allowing the catheter hub 154 to pass.

According to the third embodiment, specifically, the needle supportportion 172 has a pair of support arms 173 openable and closeable and arestraining portion 176 capable of restraining the pair of support arms173 in a closed state and also releasing the restraint.

The pair of support arms 173 is rotatably coupled to the housing 158through a pair of support pins 141. In the present illustrated example,each of the pair of support pins 141 has an axis in an upper and lowerdirection. The pair of support arms 173 supported by the pair of supportpins 141 is openable and closeable in a left and right direction. One ofthe support arms 173 has a bending engaging groove 174 a providedthereon and the other has a bending engaging groove 174 b providedthereon when viewed from the front side in the closed state. Each of theengaging grooves 174 a and 174 b passes through each of the support arms173 in a longitudinal direction.

In the present illustrated example, the one engaging groove 174 a(hereinafter, referred to as a “first engaging groove 174 a”) and theother engaging groove 174 b (hereinafter, referred to as a “secondengaging groove 174 b) both bend downward. Note that the first engaginggroove 174 a and the second engaging groove 174 b both may bend upward.Alternatively, one may bend upward and the other may bend downward.

A configuration of the pair of support arms 173 according to the thirdembodiment is similar to the pair of support arms 138 according to thesecond embodiment except the first engaging groove 174 a and the secondengaging groove 174 b. A coupling structure between the pair of supportarms 173 and the housing 158 according to the third embodiment issubstantially the same as a coupling structure between the pair ofsupport arms 138 and the housing 88 according to the second embodiment.

The restraining portion 176 is slidable with respect to the pair ofsupport arms 173, and is formed as a part of the above hub operatingportion 160. The restraining portion 176 moves forward in accordancewith a forward movement of the hub operating portion 160 so that therestraint with respect to the pair of support arms 173 is released.

Specifically, the restraining portion 176 is provided at a leading endof the main body portion 161 of the hub operating portion 160. FIG. 23is a cross-sectional view taken along line XXIII-XXIII of FIG. 21. Asillustrated in FIG. 23, the restraining portion 176 has a firstrestraining protrusion 177 a engaging with the first engaging groove 174a so as to be slidable and a second restraining protrusion 177 bengaging with the second engaging groove 174 b so as to be slidable.

In the present illustrated example, the first restraining protrusion 177a and the second restraining protrusion 177 b protrude in the samedirection so as to adapt to shapes of the first engaging groove 174 aand the second engaging groove 174 b provided on the pair of supportarms 173, respectively. When the restraining portion 176 is positionedat an initial position (backward position), the first restrainingprotrusion 177 a and the second restraining protrusion 177 b of therestraining portion 176 engage with the first engaging groove 174 a andthe second engaging groove 174 b of the pair of support arms 173,respectively. Thus, the pair of support arms 173 is restrained in aclosed state.

In accordance with a movement of the restraining portion 176 in theleading end direction, the first restraining protrusion 177 a and thesecond restraining protrusion 177 b separate from the first engaginggroove 174 a and the second engaging groove 174 b of the pair of supportarms 173 in the leading end direction, respectively. When the firstrestraining protrusion 177 a and the second restraining protrusion 177 bseparate from the first engaging groove 174 a and the second engaginggroove 174 b, respectively, the restraint of the restraining portion 176with respect to the pair of support arms 173 is released. Then, the pairof support arms 173 becomes expansible.

As illustrated in FIGS. 19 and 20, the hub operating portion 160 caninclude a protrusion for expansion 178 for opening the pair of supportarms 173, provided slightly on the base end side beyond the restrainingportion 176. The protrusion for expansion 178 is formed so as to betapered and be triangular in the present illustrated example.

Note that the respective members in the catheter assembly 10C accordingto the third embodiment, having the same terms as those in the catheterassemblies 10A and 10B according to the first and second embodimentsinclude the materials exemplified as constituent materials of those ofthe catheter assemblies 10A and 10B.

The catheter assembly 10C according to the third embodiment is basicallyconstituted as described above. Functions and effects of the catheterassembly 10C will be described below.

As illustrated in FIGS. 19 and 21, the catheter assembly 10C in theinitial state is in a state to be described below. The inner needle 156has been inserted into the catheter 152 and the needlepoint 157 hasprotruded from the leading end of the catheter 152 by the predeterminedlength. The leading end fitting portion 108 of the inner tube 104 hasbeen inserted into the base end of the catheter hub 154. The outer tube106 has maximally moved to the leading end side in a movable range withrespect to the inner tube 104. The catheter 152 and the inner needle 156have been exposed from the leading end of the housing 158, and thecatheter hub 154 and the protector 90 have been housed in the housing158. The protector 90 is positioned on the base end side in the housing158. The restraining portion 176 has been positioned at the backwardposition in a movable range. The pair of support arms 173 has beenrestrained in the closed state by the restraining portion 176. The innerneedle 156 has been held by the pair of support arms 173 in the closedstate through the catheter 152.

In the use of the catheter assembly 10C, a user (for example, a medicaldoctor or a nurse) grips the housing 158 and punctures a blood vessel ofa patient with the catheter 152 and the inner needle 156. In this case,a portion close to the leading end of the housing 158 is gripped so thatthe needlepoint 157 becomes stable and the puncture operation is easilyperformed. Upon the puncture, the pair of support arms 173 that has beenclosed supports the inner needle 156 through the catheter 152. Thus, thedeflection of the inner needle 156 upon the puncture is inhibited.Accordingly, a stable puncture can be performed.

After the puncture, a finger hooks the tab 162 provided at a leading endof the hub operating portion 160, and presses the tab 162 in the leadingend direction. In this case, a finger of a hand (for example, an indexfinger) that has gripped the part close to the leading end of thehousing 158, can operate the tab 162. Thus, transition from theoperation of the puncture to the operation of the tab 162, is promptlyperformed.

When the tab 162 is pressed in the leading end portion, the restrainingportion 176 provided on the hub operating portion 160 moves in theleading end direction with respect to the pair of support arms 173.Then, the first restraining protrusion 177 a and the second restrainingprotrusion 177 b separate from the first engaging groove 174 a and thesecond engaging groove 174 b, respectively. Due to the separation, therestraint of the restraining portion 176 with respect to the pair ofsupport arms 173 is released. Then, the pair of support arms 173 becomesexpansible.

As illustrated in FIGS. 24A and 24B, when the hub operating portion 160further moves forward, the pair of support arms 173 is pressed from therear side by the protrusion for expansion 178 so as to expand. In thiscase, the leading end portion of the hub operating portion 160 isflexible at a part of a thin-walled portion 161 a. Thus, the leading endof the hub operating portion 160 can be prevented from interfering withskin of the patient.

Next, as illustrated in FIG. 25, when the hub operating portion 160further moves forward, the catheter hub 154 and catheter 152 that havebeen coupled to the hub operating portion 160 further move in theleading end direction with respect to the housing 158. Thus, aninsertion length of the catheter 152 into the blood vessel increases.Meanwhile, the protector 90 coupled to the catheter hub 154 also movesforward in the housing 158 in accordance with the forward movement ofthe hub operating portion 160.

When the catheter 152 has been inserted into the blood vessel by apredetermined length, next, the housing 158 is pulled in the base enddirection with respect to the catheter member 168. Accordingly, theinner needle 156 moves in the base end direction in the catheter 152,the catheter hub 154, and the protector 90. In this case, since theleading end fitting portion 108 of the inner tube 104 of the protector90 and the catheter hub 154 have fitted to each other due topredetermined fitting force, the protector 90 extends in accordance withthe backward movement of the housing 158. Specifically, the inner tube104 moves to the side of a leading end of the outer tube 106. Inaddition, the outer tube 106 moves to the side of the leading end of thehousing 158. Accordingly, a state where the protector 90 has maximallyextended, is acquired (refer to FIG. 26). During a process during whichthe protector 90 maximally extends, the inner needle 156 is evulsed fromthe catheter 152 and the inner needle 156 is also housed in theprotector 90 with the needlepoint 157.

In a state where the protector 90 has maximally extended, a function ofthe first locking mechanism 126 prevents movements in the axialdirection of the inner tube 104 and the outer tube 106. In addition, afunction of the second locking mechanism 134 prevents movements in theaxial direction of the outer tube 106 and the housing 158.

After the protector 90 has maximally extended, when the housing 158 isfurther pulled in the base end direction with respect to the cathetermember 168, as illustrated in FIG. 27, the fit between the catheter hub154 and the leading end fitting portion 108 of the inner tube 104 comesoff. Accordingly, a state where the protector 90 has completelyseparated from the catheter member 168 and only the catheter member 168out of the catheter assembly 10C has been detained on the side of thepatient, is acquired.

After the catheter member 168 and the protector 90 have separated fromeach other, the hub operating portion 160 separates from the catheterhub 154. Specifically, in a state where the hub operating portion 160has risen so as to be in a position substantially perpendicular to thecatheter hub 154, the hub operating portion 160 is pulled upward so thatthe hub operating portion 160 separates from the catheter hub 154 (referto FIG. 22B). After that, the catheter hub 154 is fixed to the skin ofthe patient with a dressing material, a tape, or the like. A connectorof a transfusion tube, not illustrated, is coupled to the side of thebase end of the catheter hub 154, and supply of a transfusion material(a medical fluid) to the patient through the transfusion tube isperformed.

As described above, the catheter assembly 10C according to the thirdembodiment can include the catheter hub 154 housed in the housing 158 inthe initial state. Thus, as in the first and second embodiments, anentire product length can be shortened in both of the initial state andthe needlepoint protecting state due to the protector 90. According tothe third embodiment, other respective constituent portions shared withthe first and second embodiments acquire functions and effects similarto those according to the first and second embodiments.

According to the third embodiment, in the initial state, the huboperating portion 160 extends along the inner needle 156 and thecatheter hub 154. In addition, the base end portion is coupled to thecatheter hub 154 and the leading end portion is exposed on the side ofthe leading end of the housing 158. With this configuration, a portionof the hub operating portion 160 that has been exposed on the side ofthe leading end of the housing 158 is touched so that the operation withrespect to the hub operating portion 160 can be performed. Thus, thesame hand that grips the side of the leading end of the housing 158 upona puncture, can operate the hub operating portion 160. Accordingly, thesame hand can perform the puncture operation and the forward movementoperation of the catheter 152. Thus, excellent operability can beacquired.

According to the third embodiment, the restraining portion 176 isprovided as a part of the hub operating portion 160, and the restraintwith respect to the pair of support arms 173 is released upon theforward movement of the hub operating portion 160. With thisconfiguration, the restraint with respect to the pair of support arms173 is automatically released in response to the forward movement of thecatheter hub 154 based on the operation with respect to the huboperating portion 160. Thus, there is no need for an independent releaseoperation, and excellent operability can be acquired.

The catheter assembly 10C may further include a guide wire G insertedinto the inner needle 156, and a guide wire operating portion 150 foroperating the guide wire G, the guide wire operating portion 150 beingcoupled to the guide wire G (refer to FIG. 21). In this case, therestraining portion 176 may be provided as a part of the guide wireoperating portion 150. In accordance with a forward movement of theguide wire operating portion 150, the guide wire operating portion 150may press the restraining portion 176 so that the restraint with respectto the pair of support arms 173 may be released.

The detailed description above describes a catheter assembly. Theinvention is not limited, however, to the precise embodiments andvariations described. Various changes, modifications and equivalents caneffected by one skilled in the art without departing from the spirit andscope of the invention as defined in the accompanying claims. It isexpressly intended that all such changes, modifications and equivalentswhich fall within the scope of the claims are embraced by the claims.

What is claimed is:
 1. A catheter assembly comprising: a catheter; acatheter hub fixed to a proximal end portion of the catheter; a needlehaving a needlepoint, and inserted into the catheter so as to beseparable; an elongated member coupled to the needle; a protectordisplaceable in an axial direction in a range regulated with respect tothe elongated member, and configured to cover at least the needlepointof the needle in accordance with evulsion of the needle from thecatheter; and wherein, in an initial state, the catheter and the needleare exposed from a distal end of the elongated member, and the elongatedmember overlaps the catheter hub and the protector.
 2. The catheterassembly according to claim 1, further comprising: a needle supportportion configured to support the needle through the catheter on adistal end side and distally of the catheter hub; and the needle supportportion being movable with respect to the elongated member in order tochange from a first state of supporting the needle to a second state ofreleasing the support of the needle and allowing the catheter hub topass.
 3. The catheter assembly according to claim 2, wherein the needlesupport portion has a pair of support arms openable and closeable, and arestraining portion capable of restraining the pair of support arms in aclosed state and releasing a restraint of the pair of support arms. 4.The catheter assembly according to claim 1, wherein an operating portionfor operating the catheter hub is provided on the catheter hub; and inthe initial state, at least a part of the operating portion is exposedfrom the elongated member.
 5. The catheter assembly according to claim4, further comprising: wherein the elongated member includes a slitextending in the axial direction of the elongated member; and whereinthe at least the part of the operating portion exposed from theelongated member is exposed on an outside of the elongated memberthrough the slit.
 6. The catheter assembly according to claim 4, whereinthe operating portion includes a pair of flexible wings mutuallyprotruding in opposite directions from the catheter hub.
 7. The catheterassembly according to claim 1, wherein the protector is detachablyfitted to a proximal end of the catheter hub.
 8. The catheter assemblyaccording to claim 3, wherein the restraining portion is movable withrespect to the pair of support arms by a distal movement of the catheterhub, which releases the restraint with respect to the pair of supportarms.
 9. The catheter assembly according to claim 3, wherein the pair ofsupport arms are openable and closeable in a lateral direction.
 10. Thecatheter assembly according to claim 3, wherein the restraining portionis movable with respect to the pair of support arms in an axialdirection.
 11. The catheter assembly according to claim 10, wherein therestraining portion is slidable with respect to the pair of support armsin the axial direction.
 12. The catheter assembly according to claim 11,wherein the restraining portion is slidable with respect to the pair ofsupport arms by a distal movement of the catheter hub, which releasesthe restraint with respect to the pair of support arms.
 13. A catheterassembly comprising: a catheter; a catheter hub fixed to a proximal endportion of the catheter; a needle having a needlepoint, and insertedinto the catheter so as to be separable; an elongated member coupled tothe needle; a protector displaceable in an axial direction of theelongated member, and configured to cover at least the needlepoint ofthe needle in accordance with evulsion of the needle from the catheter;a needle support portion configured to support the needle through thecatheter on a distal end side and distally of the catheter hub; theneedle support portion being movable with respect to the elongatedmember in order to change from a first state of supporting the needle toa second state of releasing the support of the needle and allowing thecatheter hub to pass; the needle support portion having a pair ofsupport arms openable and closeable; a restraining portion capable ofrestraining the pair of support arms in a closed state and releasing arestraint of the pair of support arms; and wherein, in the first state,the catheter and the needle are exposed from a distal end of theelongated member, and the elongated member overlaps the catheter hub andthe protector.
 14. The catheter assembly according to claim 13, furthercomprising: an operating portion configured to operate the catheter hubdisposed on the catheter hub; and in the first state, at least a part ofthe operating portion is exposed from the elongated member.
 15. Thecatheter assembly according to claim 13, wherein the elongated memberincludes a slit extending in the axial direction of the elongatedmember; and wherein the at least the part of the operating portionexposed from the elongated member is exposed on an outside of theelongated member through the slit.
 16. The catheter assembly accordingto claim 13, wherein the operating portion includes a pair of flexiblewings mutually protruding in opposite directions from the catheter hub.17. The catheter assembly according to claim 13, wherein the protectoris detachably fitted to a proximal end of the catheter hub.
 18. Anassembly comprising: an outer needle; a hub fixed to a proximal endportion of the outer needle; an inner needle having a needlepoint, andinserted into the outer needle so as to be separable; an elongatedmember coupled to the inner needle; a protector displaceable in an axialdirection of the elongated member, and configured to cover at least theneedlepoint of the inner needle in accordance with evulsion of the innerneedle from the outer needle; and wherein, in an initial state, theouter needle and the inner needle are exposed from a distal end of theelongated member, and the elongated member overlaps the hub and theprotector.
 19. The assembly according to claim 18, further comprising: aneedle support portion configured to support the inner needle throughthe outer needle on a distal end side and distally of the hub, theneedle support portion having a pair of support arms openable andcloseable; and a restraining portion capable of restraining the pair ofsupport arms in a closed state and releasing a restraint of the pair ofsupport arms.
 20. The assembly according to claim 18, furthercomprising: an operating portion configured to operate the hub disposedon the hub, and in the initial state, at least a part of the operatingportion is exposed from the elongated member; and wherein the protectoris detachably fitted to a proximal end of the hub.